FDA In Brief: FDA warns against using SARMs in body-building products

FDA In Brief: FDA warns against using SARMs in body-building products

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"We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients. Body-building products that contain selective androgen receptor modulators, or SARMs, have not been approved by the FDA and are associated with serious safety concerns, including potential to increase the risk of heart attack or stroke and life threatening reactions like liver damage,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We will continue to take action against companies marketing these products to protect the public health."

The U.S. Food and Drug Administration recently issued warning letters to Infantry Labs, LLC, IronMagLabs and Panther Sports Nutrition for distributing products that contain SARMs. Although the products identified in the warning letters are marketed and labeled as dietary supplements, they are not dietary supplements. The products are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness.

Life threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke, and the long-term effects on the body are unknown. Consumers should stop using these body-building products immediately and consult a health care professional if they are experiencing any adverse reactions that may be associated with their use.

Health care professionals and consumers should also report any adverse events related to the use of these body-building products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

The companies that received a warning letter must respond to the FDA identifying how the problems noted by the FDA will be corrected within 15 working days. Companies that do not correct the problems risk additional enforcement action such as seizure, injunction or prosecutions.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.